Communication device, communication system and communication method for an implantable medical device

ABSTRACT

A communication device for an implantable medical device may include: an input/output interface configured to communicate with a wireless communication device; a communication interface configured to communicate with a remote system; and a processor configured to perform an analysis of data received from the wireless communication device via the input/output interface and associated with the implantable medical device. The communication device may include a user interface configured to receive data input by a user. A communication system may include a wireless communication device and the aforementioned communication device. A communication method for an implantable medical device may include: providing a communication device that is configured to communicate with a wireless communication device, to communicate with a remote system and to perform an analysis of data; communicating data associated with an implantable medical device from a wireless device to the communication device; and analyzing the received data at the communication device.

REFERENCE TO RELATED APPLICATION

This application is related to U.S. patent application Ser. No.11/555,636, filed Nov. 1, 2006, now abandoned, the entirety of which isincorporated herein by reference.

TECHNICAL FIELD

This application relates generally to implantable medical devices and,more specifically, to devices, systems and methods for communicatingwith an implantable medical device.

BACKGROUND

A conventional implantable cardiac device may be used to treat fastand/or slow arrhythmias with stimulation therapy includingcardioversion, defibrillation, and pacing stimulation. Such stimulationmay be prescribed when the patient's heart does not function normallydue to, for example, a genetic condition.

An implanted device typically includes a telemetry interface thatenables an external device to read data from the implanted device andconfigure the implanted device. For example, the implanted device maylog data relating to the cardiac activity of the patient's heart andcorrective stimulation that the implanted device applied to the heart. Atreating physician may analyze this data to determine whether to modifythe patient's treatment. In addition, based on this data or other teststhe physician may reconfigure how the device senses cardiac activity andapplies stimulation therapy.

Conventionally, the external device communicates with the implanteddevice or devices via radio frequency (“RF”) signals. For example, theexternal device connects via a lead to a telemetry head that includes anantenna. When the telemetry head is placed near the implanted device(e.g., on the patient's skin), the telemetry head may send signals toand receive signals from a corresponding telemetry circuit in theimplanted device. In general, the external device may include awireless, e.g., RF, communication element capable of communicating withthe implanted devices at relative short distances, for example, two tothree meters. The implantable cardiac device and/or a separate “sensordevice” for monitoring indicators for heart failure exacerbation may beconfigured to send and receive signals from either the telemetry head ora wireless communication element.

Traditionally, the external device is used in either a clinical settingor in a patient's home. In the latter case, the external device (e.g., acall-in system) may communicate with a remote computer via a telephoneline or cellular communications. In this way, an operator at a remotelocation may read information from the implanted device or program theimplanted device.

SUMMARY

There is a need for improved communication with implantable medicaldevices. Such communication may be to monitor a patient's condition, tomonitor performance of the implantable device, and/or to program orotherwise adjust parameters of the implantable device. In particular,monitoring the patient's condition or the performance of the implantabledevice may be for providing a corrective response or for providinghistorical data for analysis.

In one embodiment, a communication device for an implantable medicaldevice may be provided. The communication device may comprise aninput/output interface configured to communicate with a wirelesscommunication device, a communication interface configured tocommunicate with a remote system, and a processor configured to performan analysis of data received from the wireless communication device viathe input/output interface and associated with the implantable medicaldevice.

Alternatively or additionally, some embodiments may comprise a userinterface configured to receive data input by a user. In suchembodiments, the communication device may include a processor configuredto communicate data received from a wireless communication device anddata received from the user interface to a remote system.

In one embodiment, a communication system for an implantable medicaldevice may be provided. The communication system may comprise a wirelesscommunication device in conjunction with the aforementionedcommunication device.

In one embodiment, a communication method for an implantable medicaldevice may be provided. The method may comprise: providing acommunication device that is configured to communicate with a wirelesscommunication device, to communicate with a remote system and to performan analysis of data; communicating data associated with an implantablemedical device from a wireless device to the communication device; andanalyzing the received data at the communication device.

Alternatively or additionally, some embodiments may comprise: receivingdata input by a user via a user interface of the communication device;and communicating data received from the wireless communication deviceand data received from the user interface to the remote system. In suchembodiments, the method may further comprise providing an output to theuser based on a result of the analysis via the user interface. Otherembodiments may comprise receiving data from an implanted sensor device,processing the received data with the wireless communication device andsending a signal from the wireless communication device that isconfigured to adjust the cardiac device.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages will be more fullyunderstood when considered with respect to the following detaileddescription, appended claims and accompanying drawings, wherein:

FIG. 1 is a simplified diagram of an example of an implantablestimulation device in electrical communication with at least three leadsimplanted in a patient's heart for delivering multi-chamber stimulationand shock therapy;

FIG. 2 is a simplified functional block diagram of an example of amulti-chamber implantable stimulation device, illustrating basicelements that are configured to provide cardioversion, defibrillation orpacing stimulation or any combination thereof;

FIG. 3 is a simplified diagram of one embodiment of a communicationsystem;

FIG. 4 is a perspective view of an example of a communication devicethat may from part of the communication system of FIG. 3;

FIG. 5 is a simplified block diagram illustrating a telemetry head, awireless communication device and a docking station as one embodiment ofa communication system;

FIG. 6 is a simplified block diagram of a telemetry head and a cellulartelephone as part of one embodiment of a communication system;

FIG. 7 is a simplified block diagram of a cellular telephone as part ofone embodiment of a communication system;

FIG. 8 is a simplified block diagram of an example of a docking stationas one embodiment of a communication device;

FIG. 9 is a simplified block diagram of another example of a dockingstation as one embodiment of a communication device; and

FIG. 10 is a flow chart illustrating an example of a communicationmethod that may be implemented by a communication device or system withan implantable cardiac device.

DETAILED DESCRIPTION

Various details are described below, with reference to illustrativeembodiments. It will be apparent that the invention may be embodied in awide variety of forms, some of which may be quite different from thoseof the disclosed embodiments. Consequently, the specific structuraland/or functional details disclosed herein are merely representative anddo not limit the scope of the invention.

For example, based on the teachings herein it should be understood thatthe various structural and/or functional details disclosed herein may beincorporated in an embodiment independently of any other structuraland/or functional details. Thus, an apparatus may be implemented and/ora method practiced using any number of the structural and/or functionaldetails set forth in the disclosed embodiments. Also, an apparatus maybe implemented and/or a method practiced using other structural and/orfunctional details in addition to or other than the structural and/orfunctional details set forth in the disclosed embodiments.

Embodiments may provide a communication device, system and/or methodthat provide improved communication with an implantable medical device,such as an implantable cardiac device. For example, a communicationdevice may be configured to receive data from an implantable medicaldevice via a wireless communication device, analyze the received data,and send data to the implantable medical device via the wirelesscommunication device based on the analysis. The communication device maybe configured to send data to a remote system based on the analysis.This may allow the communication device to perform some analysis toprovide a relatively quick response to the implantable medical device,the user and/or the remote system. Alternatively or additionally, thecommunication device may read or receive data from one or more implantedsensor devices contained in the patient, perform analysis on the data,and then communicate to the implanted cardiac device based on the dataanalysis.

Improved communication may also be provided by a communication devicethat is configured to receive data from an implantable medical devicevia a wireless communication device and to send the received data to aremote system. In such embodiments, this capability may provide a backupor redundant mode for sending data to the remote system in addition tothe capability of the wireless communication device. In particular, sucha redundant or backup mode may provide non-wireless communication withthe remote system.

Additionally or alternatively, the communication device may beconfigured to receive data from the implantable medical device and froma user via a user interface of the communication device. This may allowthe user to provide additional data for the communication device toanalyze and/or to send to a remote system. The user interface may alsobe configured to provide an output to the user, for example, based on ananalysis of the data from the implantable medical device.

Communication provided to the implantable medical device from thecommunication device via the wireless communication device may programor otherwise adjust operating parameters of the implantable medicaldevice. Such programming or adjustment may be based on analysis of datareceived by the communication device, the analysis being performed bythe communication device and/or a remote system. Alternatively oradditionally, the one or more implantable sensor device(s) may receiveprogramming and/or calibration adjustment data based on analysisperformed by the wireless device.

Additionally or alternatively, communication provided to the wirelesscommunication device from the communication device may program and/orprovide operating or application software to the wireless communicationdevice. Such programming and/or software may provide additional orupdated capabilities to the wireless communication device, for example,for interacting with the implantable medical device, the communicationdevice and/or a remote system.

The following description sets forth one example of an implantablecardiac device (e.g., a stimulation device) that is capable of beingused in connection with the various embodiments that are describedbelow. It should be understood that other implantable medical devicesmay be used and that the description below is given to assist inunderstanding the embodiments described herein.

FIG. 1 shows an exemplary implantable cardiac device 100 in electricalcommunication with a patient's heart 102 via three leads 104, 106, and108, suitable for delivering multi-chamber stimulation and shocktherapy. To sense atrial cardiac signals and to provide right atrialchamber stimulation therapy, device 100 may be coupled to an implantableright atrial lead 104 including, for example, an atrial tip electrode120, which typically is implanted in the patient's right atrialappendage or septum. FIG. 1 shows the right atrial lead 104 as includingan optional atrial ring electrode 121.

To sense left atrial and ventricular cardiac signals and to provide leftchamber pacing therapy, the device 100 may be coupled to a coronarysinus lead 106 designed for placement in the coronary sinus region viathe coronary sinus for positioning a distal electrode adjacent to theleft ventricle and/or additional electrode(s) adjacent to the leftatrium. As used herein, the phrase “coronary sinus region” refers to thevasculature of the left ventricle, including any portion of the coronarysinus, great cardiac vein, left marginal vein, left posteriorventricular vein, middle cardiac vein, and/or small cardiac vein or anyother cardiac vein accessible by the coronary sinus.

Accordingly, an exemplary coronary sinus lead 106 may be designed toreceive atrial and ventricular cardiac signals and to deliver leftventricular pacing therapy using, for example, a left ventricular tipelectrode 122 and, optionally, a left ventricular ring electrode 123; toprovide left atrial pacing therapy using, for example, a left atrialring electrode 124; and to provide shocking therapy using, for example,a left atrial coil electrode 126 (or other electrode capable ofdelivering a shock). For a more detailed description of a coronary sinuslead, the reader is directed to U.S. Pat. No. 5,466,254, “Coronary SinusLead with Atrial Sensing Capability” (Helland), which is incorporatedherein by reference in its entirety.

The device 100 is also shown in electrical communication with thepatient's heart 102 via an implantable right ventricular lead 108including, in this implementation, a right ventricular tip electrode128, a right ventricular ring electrode 130, a right ventricular (RV)coil electrode 132 (or other electrode capable of delivering a shock),and superior vena cava (SVC) coil electrode 134 (or other electrodecapable of delivering a shock). Typically, the right ventricular lead108 is transvenously inserted into the heart 102 to place the rightventricular tip electrode 128 in the right ventricular apex so that theRV coil electrode 132 will be positioned in the right ventricle and theSVC coil electrode 134 will be positioned in the superior vena cava.Accordingly, the right ventricular lead 108 may be capable of sensing orreceiving cardiac signals, and delivering stimulation in the form ofpacing and shock therapy to the right ventricle.

The device 100 is also shown in electrical communication with a lead 110including one or more components 144 such as a physiologic sensor. Thelead 110 may be positioned in, near or remote from the heart.

It should be understood that the device 100 may connect to leads otherthan those specifically shown. In addition, the leads connected to thedevice 100 may include components other than those specifically shown.For example, a lead may include other types of electrodes, sensors ordevices that serve to otherwise interact with a patient or thesurroundings.

FIG. 2 shows an exemplary, simplified block diagram depicting variouscomponents of the cardiac device 100. The device 100 may be capable oftreating both fast and slow arrhythmias with stimulation therapy,including cardioversion, defibrillation, and/or pacing stimulation.While a particular multi-chamber device is shown, it should beunderstood that this is for illustration purposes only. Thus, it shouldbe understood that the approaches described herein may be implemented inconnection with any suitably configured or configurable device.Accordingly, the circuitry shown may be duplicated, eliminated, ordisabled in any desired combination to provide a device capable oftreating the appropriate chamber(s) with, for example, cardioversion,defibrillation, and/or pacing stimulation.

A housing 200 for the device 100 is often referred to as the “can”,“case” or “case electrode”, and may be programmably selected to act as areturn electrode for all “unipolar” modes. The housing 200 may furtherbe used as a return electrode alone or in combination with one or moreof the coil electrodes 126, 132 and 134 for shocking purposes. Thehousing 200 may further include a connector (not shown) including aplurality of terminals 201, 202, 204, 205, 206, 208, 212, 214, 216 and218 (shown schematically and, for convenience, the names of theelectrodes to which they are connected are shown next to the terminals).The connector may be configured to include various other terminalsdepending on the requirements of the device.

To achieve right atrial sensing and pacing, the connector may include,for example, a right atrial tip terminal (AR TIP) 202 adapted forconnection to the atrial tip electrode 120. A right atrial ring terminal(AR RING) 201 may also be included adapted for connection to the atrialring electrode 121. To achieve left chamber sensing, pacing, andshocking, the connector may include, for example, a left ventricular tipterminal (VL TIP) 204, left ventricular ring terminal (VL RING) 205, aleft atrial ring terminal (AL RING) 206, and a left atrial shockingterminal (AL COIL) 208, which may be adapted for connection to the leftventricular tip electrode 122, left ventricular ring electrode 123, theleft atrial ring electrode 124, and the left atrial coil electrode 126,respectively.

To support right chamber sensing, pacing, and shocking, the connectormay further include a right ventricular tip terminal (VR TIP) 212, aright ventricular ring terminal (VR RING) 214, a right ventricularshocking terminal (RV COIL) 216, and a superior vena cava shockingterminal (SVC COIL) 218, which may be adapted for connection to theright ventricular tip electrode 128, right ventricular ring electrode130, the RV coil electrode 132, and the SVC coil electrode 134,respectively.

At the core of the device 100 may be a programmable microcontroller 220that controls the various modes of stimulation therapy. As is well knownin the art, the microcontroller 220 typically may include amicroprocessor, or equivalent control circuitry, designed specificallyfor controlling the delivery of stimulation therapy, and may furtherinclude memory such as RAM, ROM and/or flash memory, logic and timingcircuitry, state machine circuitry, and I/O circuitry. Typically, themicrocontroller 220 may include the ability to process or monitor inputsignals (data or information) as controlled by a program code stored ina designated block of memory. The type of microcontroller is notcritical to the described implementations. Rather, any suitablemicrocontroller 220 may be used that carries out the functions describedherein. The use of microprocessor-based control circuits for performingtiming and data analysis functions are well known in the art.

Representative types of control circuitry that may be used in connectionwith the described embodiments may include the microprocessor-basedcontrol system of U.S. Pat. No. 4,940,052 (Mann et al.), thestate-machine of U.S. Pat. Nos. 4,712,555 (Thornander et al.) and4,944,298 (Sholder), all of which are incorporated by reference hereinin their entirety. For a more detailed description of the various timingintervals that may be used within the device and theirinter-relationship, see U.S. Pat. No. 4,788,980 (Mann et al.), alsoincorporated herein by reference in its entirety.

FIG. 2 also shows an atrial pulse generator 222 and a ventricular pulsegenerator 224 that may generate pacing stimulation pulses for deliveryby the right atrial lead 104, the coronary sinus lead 106, and/or theright ventricular lead 108 via an electrode configuration switch 226. Itshould be understood that to provide stimulation therapy in each of thefour chambers of the heart, the atrial and ventricular pulse generators222 and 224 may include dedicated, independent pulse generators,multiplexed pulse generators, or shared pulse generators. The pulsegenerators 222 and 224 may be controlled by the microcontroller 220 viaappropriate control signals 228 and 230, respectively, to trigger orinhibit the stimulation pulses.

The microcontroller 220 may further include timing control circuitry 232to control the timing of the stimulation pulses (e.g., pacing rate,atrio-ventricular (AV) delay, atrial interconduction (A-A) delay, orventricular interconduction (V-V) delay, etc.) as well as to keep trackof the timing of refractory periods, blanking intervals, noise detectionwindows, evoked response windows, alert intervals, marker channeltiming, etc., which is well known in the art.

The microcontroller 220 may further include an arrhythmia detector 234.The detector 234 may be utilized by the device 100 for determiningdesirable times to administer various therapies. The detector 234 may beimplemented in hardware as part of the microcontroller 220, or assoftware/firmware instructions programmed into the device and executedon the microcontroller 220 during certain modes of operation.

The microcontroller 220 may include a morphology discrimination module236, a capture detection module 237 and an auto-sensing module 238.These modules may optionally be used to implement various exemplaryrecognition algorithms and/or methods. The aforementioned components maybe implemented in hardware as part of the microcontroller 220, or assoftware/firmware instructions programmed into the device and executedon the microcontroller 220 during certain modes of operation.

The electrode configuration switch 226 may include a plurality ofswitches for connecting the desired terminals (e.g., that are connectedto electrodes, coils, sensors, etc.) to the appropriate I/O circuits,thereby providing complete terminal and, hence, electrodeprogrammability. Accordingly, switch 226, in response to a controlsignal 242 from the microcontroller 220, may be used to determine thepolarity of the stimulation pulses (e.g., unipolar, bipolar, combipolar,etc.) by selectively closing the appropriate combination of switches(not shown) as is known in the art.

Atrial sensing circuits (ATR. SENSE) 244 and ventricular sensingcircuits (VTR. SENSE) 246 may also be selectively coupled to the rightatrial lead 104, coronary sinus lead 106, and the right ventricular lead108, through the switch 226 for detecting the presence of cardiacactivity in each of the four chambers of the heart. Accordingly, theatrial and ventricular sensing circuits, 244 and 246, may includededicated sense amplifiers, multiplexed amplifiers, or sharedamplifiers. The switch 226 may determine the “sensing polarity” of thecardiac signal by selectively closing the appropriate switches, as isalso known in the art. In this way, a clinician may program the sensingpolarity independent of the stimulation polarity. The sensing circuits(e.g., circuits 244 and 246) may optionally be capable of obtaininginformation indicative of tissue capture.

Each sensing circuit 244 and 246 may preferably employ one or more lowpower, precision amplifiers with programmable gain and/or automatic gaincontrol, bandpass filtering, and a threshold detection circuit, as knownin the art, to selectively sense the cardiac signal of interest. Theautomatic gain control may enable the device 100 to deal effectivelywith the difficult problem of sensing the low amplitude signalcharacteristics of atrial or ventricular fibrillation.

The outputs of the atrial and ventricular sensing circuits 244 and 246may be connected to the microcontroller 220, which, in turn, may be ableto trigger or inhibit the atrial and ventricular pulse generators 222and 224, respectively, in a demand fashion in response to the absence orpresence of cardiac activity in the appropriate chambers of the heart.Furthermore, as described herein, the microcontroller 220 may also becapable of analyzing information output from the sensing circuits 244and 246 and/or the data acquisition system 252. This information may beused to determine or detect whether and to what degree tissue capturehas occurred and to program a pulse, or pulses, in response to suchdeterminations. The sensing circuits 244 and 246, in turn, may receivecontrol signals over signal lines 248 and 250 from the microcontroller220 for purposes of controlling the gain, threshold, polarization chargeremoval circuitry (not shown), and the timing of any blocking circuitry(not shown) coupled to the inputs of the sensing circuits 244 and 246 asis known in the art.

For arrhythmia detection, the device 100 may utilize the atrial andventricular sensing circuits 244 and 246 to sense cardiac signals todetermine whether a rhythm is physiologic or pathologic. It should beunderstood that other components may be used to detect arrhythmiadepending on the system objectives. In reference to arrhythmias, as usedherein, “sensing” is reserved for the noting of an electrical signal orobtaining data (information), and “detection” is the processing(analysis) of these sensed signals and noting the presence of anarrhythmia.

Timing intervals between sensed events (e.g., P-waves, R-waves, anddepolarization signals associated with fibrillation which are sometimesreferred to as “F-waves” or “Fib-waves”) may be classified by thearrhythmia detector 234 of the microcontroller 220 by comparing them toa predefined rate zone limit (i.e., bradycardia, normal, low rate VT,high rate VT, and fibrillation rate zones) and various othercharacteristics (e.g., sudden onset, stability, physiologic sensors, andmorphology, etc.) to determine the type of remedial therapy that isneeded (e.g., bradycardia pacing, anti-tachycardia pacing, cardioversionshocks or defibrillation shocks, collectively referred to as “tieredtherapy”). Similar rules may be applied to the atrial channel todetermine if there is an atrial tachyarrhythmia or atrial fibrillationwith appropriate classification and intervention.

Cardiac signals or other signals may be applied to inputs of ananalog-to-digital (ND) data acquisition system 252. The data acquisitionsystem 252 may be configured (e.g., via signal line 256) to acquireintracardiac electrogram (“IEGM”) signals or other signals, convert theraw analog data into a digital signal, and store the digital signals forlater processing and/or telemetric transmission to an external device254. The data acquisition system 252 may be coupled to the right atriallead 104, the coronary sinus lead 106, the right ventricular lead 108and other leads through the switch 226 to sample cardiac signals acrossany pair of desired electrodes.

The data acquisition system 252 also may be coupled to receive signalsfrom other input devices. For example, the data acquisition system 252may sample signals from a physiologic sensor 270 or other componentsshown in FIG. 2 (connections not shown).

The microcontroller 220 may further be coupled to a memory 260 by asuitable data/address bus 262, wherein the programmable operatingparameters used by the microcontroller 220 are stored and modified, asrequired, to customize the operation of the device 100 to suit the needsof a particular patient. Such operating parameters may define, forexample, pacing pulse amplitude, pulse duration, electrode polarity,rate, sensitivity, automatic features, arrhythmia detection criteria,and the amplitude, waveshape and vector of each shocking pulse to bedelivered to the patient's heart 102 within each respective tier oftherapy. One feature of the described embodiments may be the ability tosense and store a relatively large amount of data (e.g., from the dataacquisition system 252), which data may then be used for subsequentanalysis to guide programming of the device.

Advantageously, the operating parameters of the implantable device 100may be non-invasively programmed into the memory 260 through a telemetrycircuit 264 in telemetric communication via a communication link 266,either wired or wireless, with an external device 254, such as aprogrammer, transtelephonic transceiver, or a diagnostic systemanalyzer. The microcontroller 220 may activate the telemetry circuit 264with a control signal 268. The telemetry circuit 264 may advantageouslyallow intracardiac electrograms and status information relating to theoperation of the device 100 (as contained in the microcontroller 220 ormemory 260) to be sent to the external device 254 through an establishedcommunication link 266.

The device 100 may further include one or more physiologic sensors 270.In some embodiments, the device may include a “rate-responsive” sensorthat may provide, for example, information to aid in adjustment ofpacing stimulation rate according to the exercise state of the patient.One or more physiologic sensors 270 (e.g., a pressure sensor) mayfurther be used to detect changes in cardiac output, changes in thephysiological condition of the heart, or diurnal changes in activity(e.g., detecting sleep and wake states). Accordingly, themicrocontroller 220 may respond by adjusting the various pacingparameters (such as rate, AV Delay, V-V Delay, etc.) at which the atrialand ventricular pulse generators 222 and 224 generate stimulationpulses.

While shown as being included within the device 100, it should beunderstood that a physiologic sensor 270 may also be external to thedevice 100, yet still be implanted within or carried by the patient.Examples of physiologic sensors that may be implemented in conjunctionwith device 100 include sensors that, for example, sense respirationrate, pH of blood, ventricular gradient, oxygen saturation, bloodpressure and so forth. Another sensor that may be used is one thatdetects activity variance, wherein an activity sensor is monitoreddiurnally to detect the low variance in the measurement corresponding tothe sleep state. For a more detailed description of an activity variancesensor, the reader is directed to U.S. Pat. No. 5,476,483 (Bornzin etal.), issued Dec. 19, 1995, which patent is hereby incorporated byreference in its entirety.

The one or more physiologic sensors 270 may optionally include sensorsto help detect movement (via, e.g., a position sensor) and/or minuteventilation (via an MV sensor) in the patient. Signals generated by theposition sensor and MV sensor may be passed to the microcontroller 220for analysis in determining whether to adjust the pacing rate, etc. Themicrocontroller 220 may thus monitor the signals for indications of thepatient's position and activity status, such as whether the patient isclimbing up stairs or descending down stairs or whether the patient issitting up after lying down.

The device additionally may include a battery 276 that providesoperating power to all of the circuits shown in FIG. 2. If the device100 employs shocking therapy, the battery 276 may be capable ofoperating at low current drains (e.g., preferably less than 10 μA) forlong periods of time, and may be capable of providing high-currentpulses (for capacitor charging) when the patient requires a shock pulse(e.g., preferably, in excess of 2 A, at voltages above 200 V, forperiods of 10 seconds or more). The battery 276 also may desirablyinclude a predictable discharge characteristic so that electivereplacement time may be detected. Accordingly, the device 100 maypreferably employ lithium or similar battery technology.

The device 100 may further include magnet detection circuitry (notshown), coupled to the microcontroller 220, to detect when a magnet isplaced over the device 100. A magnet may be used by a clinician toperform various test functions of the device 100 and/or to signal themicrocontroller 220 that the external device 254 is in place to receivedata from or transmit data to the microcontroller 220 through thetelemetry circuit 264.

The device 100 may further include an impedance measuring circuit 278that may be enabled by the microcontroller 220 via a control signal 280.The known uses for an impedance measuring circuit 278 include, but arenot limited to, lead impedance surveillance during the acute and chronicphases for proper performance, lead positioning or dislodgement;detecting operable electrodes and automatically switching to an operablepair if dislodgement occurs; measuring respiration or minuteventilation; measuring thoracic impedance for determining shockthresholds; detecting when the device has been implanted; measuringstroke volume; and detecting the opening of heart valves, etc. Theimpedance measuring circuit 278 may advantageously be coupled to theswitch 226 so that any desired electrode may be used.

In the case in which the device 100 is intended to operate as animplantable cardioverter/defibrillator (ICD) device, it detects theoccurrence of an arrhythmia, and automatically applies an appropriatetherapy to the heart aimed at terminating the detected arrhythmia. Tothis end, the microcontroller 220 may further control a shocking circuit282 via a control signal 284. The shocking circuit 282 may generateshocking pulses of low (e.g., up to 0.5 J), moderate (e.g., 0.5 J to 10J), or high energy (e.g., 11 J to 40 J), as controlled by themicrocontroller 220. Such shocking pulses may be applied to thepatient's heart 102 through, for example, two shocking electrodes, andas shown in this embodiment, selected from the left atrial coilelectrode 126, the RV coil electrode 132, and/or the SVC coil electrode134. As noted above, the housing 200 may act as an active electrode incombination with the RV coil electrode 132, and/or as part of a splitelectrical vector using the SVC coil electrode 134 or the left atrialcoil electrode 126 (i.e., using the RV electrode as a common electrode).

Cardioversion level shocks may generally be considered to be of low tomoderate energy level (so as to minimize pain felt by the patient),and/or synchronized with an R-wave and/or pertaining to the treatment oftachycardia. Defibrillation shocks may generally be of moderate to highenergy level (i.e., corresponding to thresholds in the range of 5 J to40 J), delivered asynchronously (since R-waves may be too disorganized),and pertaining exclusively to the treatment of fibrillation.Accordingly, the microcontroller 220 may be capable of controlling thesynchronous or asynchronous delivery of the shocking pulses.

FIG. 3 illustrates one embodiment of a communication system 300 for animplantable cardiac device 100 implanted in a patient P. Thecommunication system 300 may include a telemetry head 302, a wirelesscommunication device 304, such as a cellular telephone, and a network312 that facilitate sending data between the implantable cardiac device100 and a remote system 308. The remote system 308 may include anoperator console from which an operator may initiate or assist with thetransfer of data between the implantable cardiac device 100 and theremote system 308. In some embodiments the remote system 308 may consistof or include a central server. In this case, a physician may access thecentral server to send data to or receive data from the implantablecardiac device 100. Further, the remote system 308 may include acapability of analyzing data received from the implantable cardiacdevice 100.

The communication system 300 may also include a communication device318, such as a docking station, that is configured to communicate withthe wireless communication device 304 and the network 312. Acommunication link 320 between the communication device 318 and thenetwork 312 may provide non-wireless communication, for example. Forexample, the communication link 320 may be a hardwired link, such as atelephone line connected to a public switched telephone network (PSTN).It should be understood that the docking station may, additionally oralternatively, include a wireless communication device. A communicationlink 322 between the communication device 318 and the wirelesscommunication device 304 may provide non-wireless communication, such asa connector or interface, or short-range wireless communication, such asradio frequency (RF).

In accordance with conventional practice, the cellular telephone 304 maycommunicate with one or more cell sites 310 in a cellular network, whichin turn may connect to the network 312 (e.g., the public telephonenetwork, the Internet, etc). The remote system 308 may also beconnected, for example, via the network 312. Accordingly, the cellulartelephone 304, the communication device 318 and/or the remote system 308may establish a connection (e.g., a call, a data connection, etc.) tosend or receive data via one or more networks.

The telemetry circuit 262 in the implantable cardiac device 100 (FIG. 2)may send telemetry signals to and/or receives telemetry signals from thetelemetry head 302 (typically referred to as a “wand”). In someembodiments the telemetry signals comprise RF signals. Other embodimentsmay incorporate other types of telemetry signals. In embodiments, thetelemetry head 302 may be incorporated into the wireless communicationdevice 304, for example, as an integrated device or as software thatprovides such functionality. It should be understood that the telemetryhead 302 may not comprise a “wand,” but may provide wireless (e.g., RF)communication and may operate with or without patient interaction.

The telemetry head 302 may be placed relatively close to the device 100when data is to be downloaded to or uploaded from the implantablecardiac device 100. For example, the implantable cardiac device 100 maybe implanted in the upper chest area of the patient (a subcutaneouspectoral implant). Accordingly, the telemetry head 302 may be placed onor just above the patient's skin or clothing in this area.

In embodiments, however, such as those in which the telemetry head 302is incorporated into the wireless communication device 304, theproximity of the wireless communication device 304 to the patient may besufficient to provide wireless communication between the implantablecardiac device 100 and the wireless communication device 304. Forexample, the implantable cardiac device 100 and the wirelesscommunication device 304 may be configured for short-range wirelesscommunication such that normal use of the wireless communication device304 may maintain a sufficiently close proximity, e.g., the patientcarrying the wireless communication device 304, by hand, by purse, bybelt, etc., may be within the short range of communication.

Where appropriate or desired, the short range may be expanded to includea room or building, such that communication may be established if thepatient sets the wireless communication device 304 down. Especially insuch circumstances, it may be useful to provide a secured communicationprotocol to establish communication only between the implantable cardiacdevice 100 and the wireless communication device 304, as opposed toanother device, such as another implantable cardiac device, that may bewithin range. Such technology is well known, for example, in relatedfields such as wireless heartrate monitors.

The telemetry head 302 may communicate with the cellular telephone 304via a communication link 314. In some embodiments the communication link314 includes a wired connection mechanism such as one or more signalleads. In this case, the telemetry head 302 may include a lead with aconnector 316 that connects to a corresponding connector on the cellulartelephone 304. In some embodiments, the communication link 314 includesa wireless connection mechanism using RF, optical or other type ofsignal. Here, both the telemetry head 302 and the cellular telephone 304may include a wireless transceiver (not shown in FIG. 3).

In embodiments in which the telemetry head 302, or its equivalent, isincorporated into the wireless communication device 304, thecommunication link 314 may be internal wiring. It should be appreciatedthat such embodiments may provide an advantage of convenience for thepatient, avoiding a need for the patient to carry, wear and/or properlyposition a separate component (the telemetry head 302). As a wirelesscommunication device such as a cellular phone is commonly kept close athand by a majority of individuals in developed countries, the patient islikely to experience little inconvenience to incorporate thecommunication system 300 into his lifestyle.

FIG. 4 illustrates an example of a docking station that may comprise thecommunication device 318 of the communication system 300 of FIG. 3. Asshown, the docking station 318 may include a cradle 324 or othersuitable structure for receiving the wireless communication device 304.The cradle 324 may include an adapter, plug or other physical interface326, for example, that is configured to engage an existing port orinterface on the wireless communication device 304 such that acommunication path may be established when the wireless communicationdevice 304 is properly positioned in the cradle 324.

Alternatively or additionally, the docking station 318 may include aport 328 that is configured to receive a cable (not shown), such as auniversal serial bus (USB) or the like, which may be configured toconnect to an existing port or interface on the wireless communicationdevice 304 such that a communication path may be established byconnecting the wireless communication device 304 to the docking station318 via the cable.

The communication link 320 may connect the docking station 318, forexample, to a telephone network as described above. Further, a powercord 330 may connect the docking station 318 to a power source, such asa power outlet or socket. Thus, the docking station 318 may beconveniently installed in any suitably wired building. As describedfurther below, because the docking station 318 is connected to a powersource, the docking station 318 may not only be powered for all of itsfunctions, but may also provide power to the wireless communicationdevice 304 while disposed in the cradle 324 or connected to the dockingstation 318 via the cable (not shown). This may also conveniently chargea battery of the wireless communication device 304 while connected tothe docking station 318.

The docking station 318 may also include a user interface 332, such as atouch screen. The user interface 332 may allow the patient to input datadirectly into the docking station 318. This may be facilitated byinteractive software implemented in the docking station 318. In additionto a display screen, the user interface 332 may include a speaker and/ormicrophone 334. Thus, both visual and audio output may be provided tothe user. Further, in view of the advancements in voice recognitionsoftware, it should be appreciated that the speaker and/or microphone334 may facilitate “hands-free” entering of data by the user into thedocking station 318.

The docking station 318 may be configured to automatically download datafrom the wireless communication device 304 upon being placed in thecradle 324 or connected to the port 328. For example, the dockingstation 318 may sense when the wireless communication device 304 isconnected and initiate a query to the wireless communication device 304to retrieve data from the implantable cardiac device 100 that is storedin the wireless communication device 304, as described further below.Data may similarly be retrieved from other implanted sensors, eitherwith or without such connection, and may be downloaded to the dockingstation 318.

FIG. 5 illustrates in more detail one embodiment of a communication link402 between a telemetry head 404 and a cellular telephone 406. Thecommunication link 402 may include a telemetry interface 408 thatconverts signals received from an antenna 410 in the telemetry head 404to signals compatible with the cellular telephone 406 and vice versa.For example, the antenna 410 may transmit and receive RF signals.Conversely, a host-side interface of a cellular transceiver 412 in thecellular telephone 406 may send and receive digital data. Accordingly,in some embodiments the telemetry interface 408 may include atransceiver with a transmitter 414 that provides RF signals to theantenna 410 and a receiver 416 that receives RF signals from the antenna410. In addition, the telemetry interface 408 may include acommunication interface 418 that supports an appropriate data format forcommunicating with the cellular transceiver 412 and/or other componentsof the cellular telephone 406.

An implanted device (not shown in FIG. 5) may support one or more of avariety of telemetry communication protocols. These protocols may usedifferent encoding schemes and transmission rates. For example, anencoding scheme may involve phase shift modulation, pulse positionmodulation, digital encoding, etc. Accordingly, the telemetry interface408 may be configured to support the protocol(s) necessary forcommunicating with a given implantable cardiac device.

With respect to the transmit path of the telemetry interface 408, thecellular transceiver 412 may send data to the telemetry interface 408via a communication bus 420. For example, the cellular telephone maysupport a bus such as the universal serial bus (USB).

In some embodiments the cellular telephone 406 may include a connector(or a receptacle, etc.) 422 that enables an external device to connectto the bus via a complimentary connector (or a receptacle, etc.) 424. Inthis case, the telemetry head 404 may include a cable with acorresponding connector.

The telemetry interface 408 may include a communication interface 418such as a bus interface that supports appropriate data formatting and/orprotocol conversion to communicate with the cellular telephone 412 overthe bus 420. Accordingly, the communication interface 418 may extractraw data from the signals received over the bus 420 and may provideresulting data to an encoder 426. As discussed above, the encoder 426may provide appropriate encoding for transmitting signals to theimplantable cardiac device. At some point in this process, the data maybe converted from digital signals to analog signals (e.g., by D/Aconverter 428). The encoded signals may be provided to the transmitter414. The transmitter 414 may amplify and filter the signals. Inaddition, the transmitter 414 may upconvert the signals to anappropriate frequency and/or data rate.

The telemetry interface 408 may include a power supply circuit (notshown) that provides power for the components of the telemetry interface408. In some embodiments the power supply circuit connects to anappropriate lead or leads on the bus 420 (e.g., a USB bus) to obtainpower for the telemetry interface 408 from the cellular telephone 406.In some embodiments the power supply circuit may include a battery.

With respect to the receive path of the telemetry interface 408, signalsfrom the antenna 410 may be provided to the receiver 416. The receiver416 may amplify and filter the received signals. In addition, thereceiver 416 may downconvert the received signals to baseband orintermediate frequency signals. A decoder 430 may decode the receivedsignals as appropriate or desired and may provide the resulting signalsto the communication interface 418 which formats the data as appropriateor desired for transmission over the bus 420. At some point in thisprocess, the data may be converted from analog signals to digitalsignals (e.g., by ND converter 432).

Data received by the cellular telephone 406 may be sent to thecommunication device or docking station as described above. For example,the cellular telephone 406 may include an input/output interface 434that is configured to send and receive data via a connector (or areceptacle, etc.) 436 that enables the cellular telephone 406 to connectto the communication device or docking station (not shown).

It should be understood that the telemetry head 404, the cellulartelephone 406 and the communication device or docking station may notalways be connected for communication therebetween. For example, thetelemetry head 404 may only be connected to the cellular telephone 406when monitoring of the implantable cardiac device or downloading datatherefrom is desired. However, in embodiments in which the telemetryhead is incorporated into the wireless communication device, thecommunication between the wireless communication device and theimplantable cardiac device may be enabled and disabled as appropriate ordesired. Further, communications between the cellular telephone 406 andthe docking station may be wireless. In such cases, it may beadvantageous to include an antenna amplifier in the docking station tofacilitate such wireless communications (e.g., via RF) by increasing therange. In general, the docking station may improve the range of wirelesstelemetry by having the docking station provide an effectively largerantenna and/or providing more power.

Also, the cellular telephone 406 may only be connected to thecommunication device or docking station when downloading monitoring datafrom or uploading of data to the cellular telephone 406 is desired. Forexample, the cellular telephone 406 may be configured to obtain datafrom the implantable cardiac device continuously or periodically, asappropriate or desired. The patient may periodically dock or otherwiseconnect the cellular telephone 406 to the communication device ordocking station, for example, daily, to download the obtained data fromthe cellular telephone 406 to the communication device or dockingstation. As noted above, this may be conveniently incorporated into thepatient's lifestyle, for example, allowing the patient to download dataand charge the cellular telephone 406 at the end of the day orovernight.

The telemetry interface 408 described with respect to FIG. 5 may beimplemented anywhere along the communication link 402. It should beappreciated that configurations other than those specifically describedherein may be utilized. For example, although not shown in a separatefigure, it should be understood that the cellular telephone may includeany or all of the components of the telemetry head and/or the telemetryinterface to be capable of communicating directly with a givenimplantable cardiac device. Further, one or more components of atelemetry interface may be incorporated into one or more of thetelemetry head, a cable, a connector, an accessory for a cellulartelephone or some other apparatus. The system may then includeappropriate connectivity (e.g., wired-based or wireless-basedcomponents) between the system components.

In FIG. 6 another example of a telemetry head 502 may include an antenna504 that is connected to one or more leads 506 in a cable 508. A housing510 attached to the cable 508 may house a telemetry interface 512. Aconnector 514 may be attached to the end of the cable 508. The housing510 may also be attached at the end of the cable 508. In this case, theconnector 514 may be connected to (e.g., mounted on or in) or integratedwith the housing 510. In some embodiments, at least a portion of theconnector 514 may be incorporated into the housing 510.

As discussed above, the connector 514 may be configured to mate with acompatible connector 516 (e.g., a USB connector or the like) on acellular telephone 518. In this way, data received via the antenna 504may be provided to a bus 518 in the cellular telephone 520 and viceversa. Further, the cellular telephone 520 may include an input/outputinterface 522 that is configured to send and receive data via aconnector (or a receptacle, etc.) 524 that enables the cellulartelephone 520 to connect to the communication device or docking station(not shown).

In some embodiments, the operation of the telemetry head and/or theuploading and downloading of data may be controlled via the cellulartelephone. Referring to FIG. 7, a cellular telephone 602 may includevarious input devices (e.g., a key pad, display soft keys, a microphone,etc.) 604 and output devices (e.g., a display, a speaker, etc.) 606. Aprocessor 608 may be configured (e.g., via software) to control theoperation of these components and control the flow of data to and from atelemetry head 610. For example, the processor 608 may be configured toestablish a connection with a remote system (not shown in FIG. 7) toinitiate uploading data from or downloading data to the implantablecardiac device (not shown in FIG. 7). The processor 608 also may beconfigured to receive a connection request from the remote device toinitiate an upload or download. To this end, the processor 608 or someother component may control data flow over an internal bus 612 between acellular transceiver component 614 and a communication interface (e.g.,a bus interface) 616 in the cellular telephone 602.

Alternatively, the processor 608 may be configured to initiate uploadingdata from or downloading data to the implantable cardiac deviceindependently. In such case, the communication interface 616 mayestablish a connection with a remote system when the processor 608directs downloading of data to the remote system.

The cellular telephone 602 may include a memory 618 or other storagedevice for temporarily storing the data from the implantable cardiacdevice prior to downloading to the remote system or the communicationdevice/docking station. The memory may allow the cellular telephone 602to continuously or periodically obtain data from the implantable cardiacdevice, for example, when a connection to a cellular network orconnection to the communication device/docking station is not possible.Thus, a patient may have the cellular telephone obtain data from theimplantable cardiac device, as appropriate or desired, and send theobtained data to the remote system or the communication device/dockingstation when convenient or accessible.

FIG. 8 illustrates a simplified block diagram of an embodiment of acommunication device or docking station 700. The docking station 700 mayinclude an input/output interface 702 that is configured to send andreceive data from a wireless communication device (not shown), forexample, via a connector 704. In the embodiment shown, the dockingstation 700 may also include a charging device 706 that allows thedocking station 700 to supply power to and/or charge the wirelesscommunication device while connected to the connector 704. As discussedabove, the communications between the docking station 700 and thewireless communication device may be wireless, and the docking station700 may include an antenna amplifier (not shown) to facilitate suchwireless communications.

The docking station 700 may include a processor 708 that is configuredto control operation of the various components of the docking station700. Further, the processor 708 may be configured to analyze data of theimplantable cardiac device received from the wireless communicationdevice. Thus, the docking station 700 may be capable of data analysisthat allows the patient and/or the clinician to be provided with aresult of the analysis without requiring further communication to aremote system for analysis. Further, the local analysis may allow thedocking station 700 to reprogram or adjust operating parameters of theimplantable cardiac device by sending data to the implantable cardiacdevice via the wireless communication device, without requiring furthercommunication to the remote system for analysis. This may save time byavoiding delays in analysis and/or communication, which may be criticalfor the patient.

The docking station 700 may include a memory 710 for temporarily storingdata received from the wireless communication device. The memory 710 mayalso facilitate operations of the processor 708 in a manner known in theart.

As discussed above with respect to FIG. 4, the docking station 700 mayinclude a user interface 712 that allows a user to input data inaddition to the data received from the wireless communication device.The processor 708 may be configured to use the data input via the userinterface 712 to analyze the data received from the wirelesscommunication device and/or otherwise incorporate the data input via theuser interface 712 with the analysis and/or the raw data received fromthe wireless communication device, for example, for transmission to aremote device (not shown).

The processor 708 may use a communication interface 714 to communicatewith the remote system via a suitable connector 716. The communicationinterface 714 may comprise a land-line modem and/or a wireless (e.g.,cellular) interface. As discussed above, the connector 716 may be atelephone jack for connecting the docking station 700 to a telephonenetwork. Communication to the remote system may provide information tothe clinician or other appropriate service providers, as well as tofacilities that may provide further analysis of the data. Communicationto the remote system may thus facilitate a more complete evaluation ofthe patient's condition and/or the implantable device's operation, whichmay be useful for continued care of the patient, as well as for medicalstudies in general.

FIG. 9 illustrates a simplified block diagram of another embodiment of acommunication device or docking station 800. Similar to the dockingstation 700 described with respect to FIG. 8, the docking station 800may include a processor 808, a memory 810, a user interface 812, acommunication interface 814 and a connector 816, which may providesimilar functions. Instead of the input/output interface 702 andconnector 704, however, the docking station 800 may include a wirelessinterface 802 that is configured to send and receive data from awireless communication device (not shown).

In the embodiment shown, the docking station 800 may also includedetector 804 that is configured to sense when the wireless communicationdevice is within range of the docking station 800 for wirelesscommunication. For example, rather than physically connecting thewireless communication device to the docking station 800, the dockingstation 800 may initiate or establish communication with the wirelesscommunication device upon detection thereof. This may reduce or eveneliminate a need for the patient to remember to dock or connect thewireless communication device to the docking station 800 to downloaddata. This may also provide more frequent downloading of data, which mayenhance patient care, for example, by providing more frequent analysisof data and/or adjustments of the implantable cardiac device.

In any of the embodiments of the communication device/docking station,the communication device/docking station may be configured to provideall or nearly all of the functionality required for obtaining data fromand providing data to the implantable cardiac device, for example, suchthat a conventional wireless communication device may be used. Forexample, the communication device/docking station may include a suitableencoder, decoder and/or converters to facilitate communications with thewireless communication device, the implantable cardiac device and theremote system.

Alternatively or additionally, the communication device/docking stationmay be configured to provide a conventional wireless communicationdevice with software that adds new features or functions to the wirelesscommunication device. Thus, the communication device/docking station maybe configured to provide updates to the wireless communication device,in addition to providing updates to the implantable cardiac device.

Referring now to FIG. 10, a flow chart illustrating an embodiment of acommunication method that may be implemented by a communication deviceor system, such as described above, with an implantable cardiac deviceis shown. It should be understood that the various steps shown may beoptional and that other steps may be added as desired, and that theorder of steps shown may be rearranged as desired. The flow chart isintended to illustrate one non-limiting example for the sake ofunderstanding a general approach to communicating with an implantablecardiac device, and is not intended to encompass all of thepossibilities contemplated herein and/or permutations that may beappropriate for a given application.

Beginning in step S100, a communication between the implantable cardiacdevice and the wireless communication device may be initiated. It shouldbe understood that the communication may be via a separate telemetryhead or via suitable circuitry in the wireless communication device, asdescribed herein.

The communication may be initiated at the direction of the implantablecardiac device or the wireless communication device. For example, theimplantable cardiac device may continuously or periodically “search” fora compatible wireless communication device or a specified wirelesscommunication device with which to communicate, or may continuously orperiodically transmit data so that communication may be established byreceipt of the transmission by the wireless communication device.

Alternatively, the wireless communication device may continuously orperiodically “search” for the implantable cardiac device. Once locatedwithin range for wireless communication, the implantable cardiac devicemay automatically transmit data or otherwise initiate the communication,or the wireless communication device may initiate the communication, forexample, by querying the implantable cardiac device for data to initiatethe communication.

As yet another alternative, a user, such as the patient, may initiatethe communication between the implantable cardiac device and thewireless communication device, for example, using the wirelesscommunication device or the telemetry head, when provided.

In any case, once the communication is established, data from theimplantable cardiac device is downloaded to the wireless communicationdevice in step S200. The downloading of data may be via any suitabletype of transmission, such as RF.

In step S300, a communication between the wireless communication deviceand the docking station (communication device) may be initiated. Asdescribed above, the communication may be initiated at the direction ofthe docking station. For example, the docking station may continuouslyor periodically “search” for a compatible wireless communication deviceor a specified wireless communication device with which to communicate.Although not described above, it should be understood that the wirelesscommunication device may be configured to continuously or periodically“search” for a compatible docking station or a specified docking stationwith which to communicate. Once located within range for wirelesscommunication, the wireless communication device may automaticallytransmit data or otherwise initiate the communication, or the dockingstation may initiate the communication, for example, by querying thewireless communication device for data.

Alternatively, the wireless communication device and/or the dockingstation may initiate the communication by connecting the wirelesscommunication device to the docking station, for example, by placing thewireless communication device in the cradle of the docking station. Onceconnected, the wireless communication device may automatically transmitdata or otherwise initiate the communication, or the docking station mayinitiate the communication, for example, by querying the wirelesscommunication device for data to initiate the communication.

As yet another alternative, a user, such as the patient, may initiatethe communication between the implantable cardiac device and thewireless communication device, for example, using the wirelesscommunication device or the docking station, when connected or withinapparent wireless range.

In any case, once the communication is established, data from thewireless communication device is downloaded to the docking station instep S400. Again, the downloading of data may be via any suitable typeof transmission.

In step S500, the user or patient may input data into the dockingstation via the user interface of the docking station. The user inputdata may be, for example, related to any medically relevant informationof which the user is aware and that the implantable cardiac device isnot configured to provide. For example, the patient may input hisgeneral condition, such as fatigued, or other relevant factors, such asexercise or exertion recently performed. If not associated with theimplantable cardiac device or the docking station, the patient may inputpersonal data, for example, by entering the data or a code that isassociated with his personal and/or medical information. The user mayenter, for example, weight, blood pressure, number of pillows requiredfor sleep or answers to specific questions provided from the clinic (forexample, downloaded to the docking station) about medications or otherfactors for tailored patient care. Thus, the user interface may be usedto enter additional information that supplements and/or identifies thedata from the implantable cardiac device.

The docking station may perform an analysis of the data received fromthe user interface and/or the wireless communication device in stepS600. For example, the docking station may perform an analysis thatidentifies problems with the patient's health and/or the operation ofthe implantable cardiac device. In particular, a change in the patient'scondition, such as left atrial pressure (LAP), pulmonary embolism (PE),cardiogenic impedance, ischemia, etc., may be detected that may requirecorrective action other than that which the implantable cardiac deviceis currently configured to perform. If the patient has other implantablesensors, the data from such sensors may be combined and used as part ofthe analysis discussed above.

In step S700, the result(s) of the analysis performed by the dockingstation in step S600 may be communicated to the user. For example, avisual and/or audio communication may be provided to the patient via theuser interface of the docking station. Alternatively, a separate contactof the patient can occur, for example, via a SMS (short message service)message via a cell phone, a landline telephone call, or any othersuitable communication.

Although not shown, step S700 may include communicating the result(s) ofthe analysis performed by the docking station in step S600 to thepatient's physician, a local ambulance service and/or a local hospital.Thus, it will be appreciated that the communication provided in stepS700 may be an “alert” to the patient and/or others trained to deal witha particular condition, for example, indicated by the result(s).

Also, the result(s) of the analysis performed by the docking station instep S600, the information input by the user via the user interfaceand/or the raw data received by the docking station from the wirelesscommunication device may be communicated to a suitable remote system.The remote system may be configured to provide further analysis of theresult(s) and/or the raw data, to collect the result(s) and/or the rawdata, to communicate the result(s) and/or the raw data to appropriateparties (e.g., physicians, medical researchers, etc.), and/or to provideany other known or hereafter developed useful service. For example, thedocking station may provide the user with an option of obtainingmessages and/or specific instructions from the physician when thewireless communication device is docked or otherwise in communicationwith the docking station. The docking station may be configured toprovide software updates to the wireless communication device, forexample, to automatically update the wireless communication device witha new version of software when the wireless communication device isdocked or otherwise in communication with the docking station.

In step S900, either based on the result(s) of the analysis performed bythe docking station in step S600 and/or result(s) of the analysisperformed by the remote system in step S800, a determination may be maderegarding any adjustments to operating parameters or other programmingof the implantable cardiac device in response. For example, theresult(s) of the analysis may indicate that a different pacingconfiguration is appropriate or that a different threshold forcorrective action by the implantable cardiac device should be set toimprove the health of the patient and/or reduce the patient's risk toadverse cardiac conditions.

If adjustments to the operating parameters or other programming of theimplantable cardiac device are determined in step S900, then suchadjustments and/or programming may be communicated to the implantablecardiac device. For example, such communication may be made to thewireless communication device via the docking station, for example, whenthe wireless communication device is connected to the docking station orwithin range of wireless communication from the docking station.Alternatively, such adjustments and/or programming may be communicateddirectly to the wireless communication device, for example, from theremote system. Further, when appropriate or desired, the patient may berequested to go to a facility, such as a hospital or physician's office,to have the adjustments and/or programming communicated to theimplantable cardiac device.

Although not illustrated in the flow chart of FIG. 10, it should beunderstood that other functions or operations may be performed by acommunication device, communication system or communication method forcommunicating with an implantable cardiac device. For example, asdescribed above, the docking station may be configured to add software,updates or other features to the wireless communication device (e.g.,cell phone) as appropriate or desired.

The docking station may be used to perform offline analyses (i.e.,analyses conducted by the docking station without being in communicationwith the remote system) on raw data collected by the implanted device.While the wireless communication devices, such as cell phones, may beused to collect raw data from the implanted device for forwarding to thedocking station or the remote system, such wireless communicationdevices typically are not capable of performing such offline analysesdue to insufficient memory or processing power. The capability of thedocking system to provide offline analysis capability allows adetermination to be made locally regarding a patient condition (e.g.,LAP, PE, cardiac impedance, ischemia detection, etc.) and whether thecondition warrants the sending of an alert to the patient locally viathe docking station or cell phone or to the patient's physician via theremote system.

While a patient may enter data into, and receive feedback from, the datainterfaces (e.g., keypad and screen) of a wireless communication device,such as a cell phone, such data interfaces are small and not overly userfriendly for a patient, much less an elderly patient. Advantageously,the data interfaces (e.g., key pad, touch screen, display screen, etc.)of the docking station provide the patient with enlarged anduser-friendly data interfaces.

Although communication to the remote system is illustrated as being viathe docking station, it should be understood direct wirelesscommunication from the wireless communication device to the remotesystem may be possible, with communication via the docking station beingan alternative or backup method. For example, the wireless communicationdevice (e.g., cell phone) may communicate with the implanted medicaldevice via RF or other communication means to obtain information, whichthe cell phone communicates to the remote system via a cell network.However, the patient may travel into an area wherein the cell phone isunable to communicate with the remote system (e.g., an area without cellcoverage). As the person engages in activities within the area withoutcell coverage, the cell phone continues to communicate with theimplanted medical device and stores the communicated information in amemory of the cell phone. Upon cell coverage becoming available, thecell phone may communicate the stored information to the remote systemvia the cell network. However, in the event cell coverage does not againbecome available or the patient simply prefers to analyze the storedinformation locally, the cell phone may be placed in the docking stationand the stored information may be downloaded into the docking station.The docking station may then forward the stored information to theremote system, or the docking station may analyze locally the storedinformation.

Further, although not specifically illustrated in FIG. 10, it should beunderstood that data from one or more implanted sensors may becommunicated to the wireless communication device, and then communicatedto and processed by the docking station. The data analysis may allow thedocking station to provide information or control signals to theimplanted medical device via the wireless communication device.

A method of communicating information received from an implantablemedical device 100 is disclosed herein and discussed with reference toFIGS. 3 and 4. In one embodiment, the method includes wirelesslycommunicating information from the implanted medical device 100 to awireless communication device 304, such as a cellular telephone 304. Itis determined if wireless communication can be established between thewireless communication device 304 and a remote system 308 at a firstpoint in time. If it is determined that wireless communication can beestablished between the wireless communication device 304 and the remotesystem 308 at the first point in time (e.g., because cell coverage isavailable), the information is wirelessly communicated to the remotesystem 308. However, if it is determined that wireless communicationcannot be established between the wireless communication device 304 andthe remote system 308 at the first point in time (e.g., because cellcoverage is not available), the information is stored in a memory 618(see FIG. 7) of the wireless communication device 304 until theinformation can be communicated to which ever of the remote system 308or a docking station 318 to be first placed in communication with thewireless communication device 304 at a second point in time subsequentto the first point in time.

In one embodiment, if the information is communicated to the dockingstation 318, the docking station 318 is employed to analyze theinformation. Further, in such an embodiment, the information may beforwarded from the docking station 318 to the remote system 308.

Another method of communicating information received from an implantablemedical device 100 is disclosed herein and discussed with reference toFIGS. 3 and 4. In one embodiment, the method includes wirelesslycommunicating information from the implanted medical device 100 to awireless communication device 304, such as a cellular telephone 304. Itis determined if a local analysis of the information is preferred overanalysis via a remote system 308. If it is determined that localanalysis is preferred over analysis via the remote system 308, theinformation is stored in a memory 618 (see FIG. 7) of the wirelesscommunication device 304 and delivered to a docking station 318. If itis determined that analysis via the remote system 308 is preferred overlocal analysis, the information is delivered to the remote system 308.

In one embodiment, if the information is communicated to the dockingstation 318, the docking station 318 is employed to analyze theinformation. In such an embodiment, the docking station 318 may alsoforward the information to the remote system 308. In one embodiment, ifthe information is communicated to the remote system 308, the remotesystem is employed to analyze the information.

It should be appreciated from the above that the various structures andfunctions described herein may be incorporated into a variety ofapparatuses and implemented in a variety of ways. Different embodimentsof the device may include a variety of hardware and software processingcomponents. In some embodiments, hardware components such as processors,controllers, state machines and/or logic may be used to implement thedescribed components or circuits. In some embodiments, code such assoftware or firmware executing on one or more processing devices may beused to implement one or more of the described operations or components.

The components and functions described herein may be connected and/orcoupled in many different ways. The manner in which this is done maydepend, in part, on whether and how the components are separated fromthe other components. In some embodiments some of the connections and/orcouplings represented by the lead lines in the drawings may be in anintegrated circuit, on a circuit board or implemented as discrete wiresor in other ways.

The signals discussed herein may take several forms. For example, insome embodiments a signal may comprise electrical signals transmittedover a wire, light pulses transmitted through an optical medium such asan optical fiber or air, or RF waves transmitted through a medium suchas air, etc. In addition, a plurality of signals may be collectivelyreferred to as a signal herein. The signals discussed above also maytake the form of data. For example, in some embodiments an applicationprogram may send a signal to another application program. Such a signalmay be stored in a data memory.

While certain exemplary embodiments have been described above in detailand shown in the accompanying drawings, it is to be understood that suchembodiments are merely illustrative of and not restrictive of the broadinvention. In particular, it should be recognized that the teachingsprovided herein apply to a wide variety of systems and processes. Itwill thus be recognized that various modifications may be made to theillustrated and other embodiments described herein, without departingfrom the broad inventive scope thereof. In view of the above it will beunderstood that the invention is not limited to the particularembodiments or arrangements disclosed, but is rather intended to coverany changes, adaptations or modifications which are within the scope andspirit of the disclosure provided herein.

1. A method of communicating information received from an implantablemedical device, the method comprising: wirelessly communicatinginformation from the implanted medical device to a wireless handheldcommunication device; and for information that may be analyzed bothlocally and remotely, determining, at either the wireless handheldcommunication device or a docking station, if a local analysis of theinformation is preferred over analysis via a remote system, wherein, ifit is determined that local analysis is preferred over analysis via theremote system, storing the information in a memory of the wirelesshandheld communication device and delivering the information to thedocking station, wherein, if it is determine that analysis via theremote system is preferred over local analysis, delivering theinformation to the remote system.
 2. The method of claim 1, wherein ifthe information is communicated to the docking station, furthercomprising employing the docking station to analyze the information. 3.The method of claim 1, further comprising forwarding the informationfrom the docking station to the remote system.
 4. The method of claim 1,wherein if the information is communicated to the remote system, furthercomprising employing the remote system to analyze the information. 5.The method of claim 1, wherein the wireless handheld communicationdevice is a cellular telephone.